510(k) Report

Devices descending from K051628

230 later devices reach Infinity Monitors with Scio Modifications through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K253034HemoSphere Stream ModuleEdwards Lifesciences20250—
+8K242728BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.202502
+8K250515EpiMonitorEmpatica S.r.l.20250—
+8K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—
+8K242750Central StationNihon Kohden Digital Health Solutions, LLC20251—
+8K240596Cerebral Autoregulation Index (CAI) AlgorithmEdwards Lifesciences20240—
+8K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—
+8K233984Acumen Assisted Fluid Management (AFM) Software FeatureEdwards Lifesciences, LLC20240—
+8K240312Infinity CentralStation WideDraeger Medical Systems, Inc.20240—
+8K232694Central Monitoring System (MFM-CMS)Edan Instruments, Inc.202411
+8K230612Edwards Algorithm for Measurement of Blood HemoglobinEdwards Lifesciences, LLC20235—
+8K230842SignalHF (IM008)Implicity, Inc.20230—
+8K231248Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced…Edwards Lifesciencess, LLC202362
+8K220308Patient Monitor: RespArrayEdan Instruments, Inc.20221—
+8K221203AHI SystemFifth Eye, Inc.20220—
+8K212227Philips MR Patient Care PortalInvivo Corporation202101
+8K212208Philips IntelliVue GuardianSoftware (Rev. E.0X)Philips Medizin Systeme Boeblingen GmbH20210—
+8K202336Patient MonitorEdan Instruments, Inc.202131
+8K202189GraffitiGe Medical Systems Information Technologies, Inc.20200—
+8K152330Expression MR400 MRI Patient Monitoring SystemInvivo Corporation201521
+8K132359Mri Patient Monitoring SystemInvivo Corporation20130—
+9K260211Dashboard (P007000)Hill-Rom, Inc.20260—
+9K250349Vista CMSShanghai Draeger Medical Instrument Co., Ltd.20260—
+9K242909FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensorsEdwards Lifesciences, LLC20250—
+9K240320Patient Monitor (RespArray)Edan Instruments, Inc.20240—
+9K232962Patient Monitor (iX10, iX12, iX15)Edan Instruments, Inc.202421
+9K212271smart-syncNorthh Medical GmbH20220—
+9K1829003880 MRI Patient Monitoring SystemIradimed Corporation20180—
+10K252250Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model…Shanghai Draeger Medical Instrument Co., Ltd.20260—
+10K250179Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)Edan Instruments, Inc.20250—